Health Behavior Feedback Study for Veterans With Hepatitis C

NCT00229580 | Completed Phase 1

• 1 other identifier: 03-8752-V 03
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to explore whether a brief (3 session) intervention would impact health behavior of veterans with hepatitis C. The main focus of the intervention was on reduction of heavy drinking with patients who have liver disease. Other study goals were to increase the likelihood that patients would seek out substance use treatment and/or hepatitis C health care services. The study also tested the use of a liver function test called CDT/GGT in detecting heavy drinking. The main hypothesis was that a 3 session intervention with personalized feedback about health behavior would result in a reduction in alcohol use and increased use of substance use treatment and hepatology health care.

Conditions

Alcoholism; Alcohol Abuse; Hepatitis C; Liver Disease

Keywords

Brief Intervention; Motivational Interviewing; Health Psychology; Alcohol; Hepatitis C; Patient Education

Outcome Measures

Primary Outcomes (1)

• Reduction in alcohol consumption

  at 6 and 12-week follow-up.

Secondary Outcomes (1)

• Engagement in substance use treatment and hepatitis C specialty care. Detection of elevated CDT in blood serum compared with self-reported heavy drinking.

  12 weeks post-study

Study Arms (2)

1

EXPERIMENTAL

Motivational feedback

Behavioral: 3 session brief intervention with health behavior feedback

2

ACTIVE COMPARATOR

treatment as usual

Other: treatment as usual

Interventions

3 session brief intervention with health behavior feedback BEHAVIORAL

1

treatment as usual OTHER

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive serology for current infection by hepatitis C viremia by PCR confirmation test;
• Current alcohol use (past 30 days) as indicated by self-report (using AUDIT- C questions);
• Meets hazardous alcohol use criteria as measured by the Alcohol Use Disorders Identification Test.
• Criteria per (National Institute on Alcohol Abuse and Alcoholism, 1995):
• for women, 7 or more drinks per week or 4 or more drinks per occasion;
• for men, 14 or more drinks per week or 5 or more drinks per occasion;
• Not currently engaged (past 30 days) in VA specialty substance use disorder treatment or mutual help groups like AA/NA.

You may not qualify if:

• Abstinent from alcohol use in last 30 days as indicated by self-report or less than hazardous use according to criteria listed above by the AUDIT.
• Patient is already engaged (past 30 days) in specialty substance use disorder treatment or attends self-help groups.

Sponsors & Collaborators

• University of Washington: lead
• Alcoholic Beverage Medical Research Foundation: collaborator

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Alcoholism; Hepatitis C; Liver Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Digestive System Diseases

Study Officials

• Tania M Davis Correale, PhD

  Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 29, 2005
• Study Start: December 1, 2003
• Study Completion: January 1, 2006
• Last Updated: November 30, 2007

Record last verified: 2007-11

Locations

US (1)